Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Application
The Amendments and Remarks filed on 07/22/26 are acknowledged.
Claims 1, 10, and 19 were amended.
New claims 28-29 were added.
Claims 1-29 are included in the prosecution.
Response to Amendments/Arguments
Claim rejection under 35 USC § 103
Applicant amended independent claims 1, 10, and 19 to recite that the single-unit dosage form comprises an oblong tablet, an oval tablet, or a capsule shaped tablet. Newly added independent claim 28 also recites the same limitation. In light of these amendments, Applicant’s arguments (Pages 7-12, filed 07/22/26) regarding the rejection of claims 1-27 under 35 U.S.C. 103 as being unpatentable over Reddy et al. (US 2022/0017465 A1 – “Reddy”) in view of Newton et al. (US 5,374,430 – “Newton”) have been fully considered and are persuasive. Therefore, the obviousness rejection is withdrawn.
Maintained & Updated Rejections – necessitated by Amendment
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-27 are again rejected and new claims 28-29 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,427,540 (“the ‘540 Patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a single-unit dosage form, comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof, in an amount equivalent to about 15 mg to about 25 mg of freebase form of the compound of Formula (I), wherein the single-unit dosage form comprises a length of about 10 mm to about 20 mm and a width of about 1 mm to about 10 mm, and therefore, encompass overlapping or coextensive subject matter.
The difference is that claim 1 of the ‘540 Patent recites a method of treating an essential tremor in a subject in need thereof comprising administering to the subject an effective amount of an anhydrous crystalline Form C hydrochloride of Formula (II), whereas instant claims are drawn to a single-unit dosage form.
However, the same active ingredient, i.e., Formula II, is disclosed in both sets of claims, and one of ordinary skill in the art would have found it obvious to administer the same active ingredient known for treatment of the same condition, i.e., essential tremor.
Claim 1 of the ‘540 Patent recites an x-ray powder diffraction (XRPD) pattern which is not recited in the instant claims. However, since the same compound is recited in both sets of claims, the same properties, such as the XRPD pattern, as well as the DSC profile recited in claim 5 of the ‘540 Patent, would have been expected.
Claim 6 of the ‘540 Patent recites an oral dosage form, claims 7 and 8 recite a modified release polymer and hydroxypropyl methylcellulose, respectively, which are recited in instant claims 2, 3, 11, 12, 20, and 21, thereby rendering these limitations obvious.
Instant claims 4-9, 13-18, and 22-27 recite additional components which are not specifically recited in claims of the ‘540 Patent. However, since claims of the ‘540 Patent do not recite closed language, e.g., “consisting of,” they are considered open and allow inclusion of the components recited in the instant claims.
Instant claims 1, 10, 19, and 28 recite that the single-unit dosage form comprises an oblong tablet, an oval tablet, or a capsule shaped tablet, whereas claims of the ‘540 Patent do not specify a shape of a dosage form. However, one of ordinary skill in the art would have found it obvious to use the method recited in claims of the ‘540 Patent and use various suitable shapes of dosage forms in order to efficaciously deliver the active ingredient to treat an essential tremor in a subject.
Therefore, instant claims are obvious over claims of the ‘540 Patent and they are not patentably distinct over each other.
Claims 1-27 are again provisionally rejected and new claims 28-29 are also provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 68-94 of copending Application No. 19/312,128 (“the ‘128 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a single-unit dosage form, comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof, in an amount equivalent to about 15 mg to about 25 mg of freebase form of the compound of Formula (I), wherein the single-unit dosage form comprises a length of about 10 mm to about 20 mm and a width of about 1 mm to about 10 mm, and therefore, encompass overlapping or coextensive subject matter.
Although claims of the ‘128 Application do not recite that the single-unit dosage form comprises an oblong tablet, an oval tablet, or a capsule shaped tablet, claim 68 of the ‘128 Application recites that the single-unit dosage form comprises a length of about 10 to about 20 mm and a width of about 1 mm to about 10 mm. One of ordinary skill in the art would have found the oblong tablet, oval tablet, or capsule shaped tablet of instant claims 1, 10, 19, and 28 obvious over the dimensions of the dosage form recited in claim 68 of the ‘128 Application.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant’s arguments (Page 12, filed 07/22/26) with respect to the nonstatutory double patenting rejection over the ‘540 Patent and the provisional nonstatutory double patenting rejection over the ‘128 Application have been fully considered but are not persuasive.
Applicant argues that upon finalization of claims and indication of allowable subject matter, Applicant will consider filing Terminal Disclaimer(s) (TDs), if appropriate.
Until such time that TDs are filed the double patenting rejections will be maintained for the reasons given above.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. FDA (“Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules – Guidance for Industry, Revision 1”, October 2022, total 10 pages – “FDA”) is cited as art of interest for teaching that “Individuals who find it difficult to swallow tablets and capsules frequently cite the size as the main reason for the difficulty in swallowing” (Page 2, section II, 1. 1st ¶, last 3 lines). FDA also teaches that: “For any given size, certain shapes may be easier to swallow than others … Studies in humans have also suggested that oval tablets may be easier to swallow and have faster esophageal transit times than round tablets of the same weight” (Page 3, section 2., 1st ¶, lines 1-4). However, FDA does not teach or suggest single-unit dosage forms comprising an oblong tablet, an oval tablet, or a capsule-shaped tablet comprising a length of about 10 mm to about 20 mm, a width of about 1 mm to about 10 mm, and the compound of Formula (I) as recited in the instant claims.
Conclusion
No claims are allowed.
Since this new rejection was necessitated by applicant’s amendment, THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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